Brain Metabolism in Polycystic Ovary Syndrome
Brain Metabolism in Women With Polycystic Ovary Syndrome: a PET/MRI Study
1 other identifier
observational
7
0 countries
N/A
Brief Summary
The purpose of this study is to investigate whether higher insulin resistance in young women with Polycystic ovary syndrome (PCOS) is associated with reduced cerebral metabolic rate of glucose (CMRglu). Brain volumes using magnetic resonance imaging (MRI) and quantitative cerebral glucose uptake using dynamic positron emission tomography (PET) were obtained.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedResults Posted
Study results publicly available
May 2, 2019
CompletedMay 2, 2019
April 1, 2015
4.5 years
March 27, 2015
July 27, 2017
January 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Global Brain Glucose PET Uptake
Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography.
Single point in time (day 1)
Brain MR Volumes
T1-weighted brain MR images were obtained on a 1.5 Tesla scanner. Regional volumes were determined using FreeSurfer Suite 5.0 software.
Single point in time (day 2)
Insulin Resistance (HOMA2-IR)
The homeostasis model assessment computational method was used to estimate insulin resistance (HOMA2-IR) from fasting plasma glucose and insulin. The HOMA2-IR is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (normal young adult). A higher score indicates a lower insulin sensitivity.
Single point in time (day 1 during the FDG PET)
Study Arms (1)
POLYCYSTIC OVARY SYNDROME (PCOS)
FDG PET scan,T1-weight MRI and blood were obtained for each participant
Eligibility Criteria
Women with PCOS (n=7) were referred by physician specialist in endocrinology between March, 2010 and September, 2013. The diagnosis of PCOS was based on clinical examination using the Rotterdam criteria.
You may qualify if:
- Diagnosis of PCOS
- Age ≤ 35 y
- BMI ≤ 35
You may not qualify if:
- Taking medications for diabetes or insulin-sensitizing drugs
- Drug addictions
- Psychiatric illness
- Smoking
- Overt evidence of heart, liver or renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Blood plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephen Cunnane
- Organization
- USherbrooke
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2015
First Posted
April 7, 2015
Study Start
March 1, 2010
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
May 2, 2019
Results First Posted
May 2, 2019
Record last verified: 2015-04